Substance, Product, Organisation and Referential (SPOR) communication update

Transcription

1 Substance, Product, Organisation and Referential (SPOR) communication update December 2016 Presented by: Agnieszka Laka SPOR Change Team An agency of the European Union

2 Agenda Update on key communication activities since last SPOR TF meeting Revision of SPOR stakeholder engagement plans Confluence one place for SPOR Change Network Upcoming communication activities 1

3 Update on key communication activities since last SPOR TF meeting 2

4 Update on key communication activities since last SPOR TF meeting July Aug Sep Oct Webinars to inboard industry CLs Introduction to SPOR broadcast Update on SPOR via Telematics report to MB Webinar to Industry CLs: intro to SPOR training Update on SPOR to GMP GDP IWG NCAs Change Liaisons F2F IT Directors F2F Update on SPOR via Telematics report to MB Nov EUTMB Dec EUNDB/ SPOR TF SPOR 2nd implementation questionnaire issued to NCAs Webinar with NCAs CLs: preparation for F2F / SPOR training Open Meds workshop TOPRA HMA Bratislava PhUSE Conference Barcelona Open Meds conference Athens 3

5 Revision of SPOR stakeholder engagement plans 4

6 Revision of stakeholder engagement plans Update on RMS & OMS UAT and go live Impact on change management activities, milestones Plans are being revised Update expected in January 5 Change Liaisons

7 Change Liaision activities & milestones Training milestones Programme milestones Revision of training plan Aug Sep Oct Nov Dec Jan Feb 01-Aug 08-Aug 15-Aug 22-Aug 29-Aug 05-Sep 12-Sep 19-Sep 26-Sep 03-Oct 10-Oct 17-Oct 24-Oct 31-Oct 07-Nov 14-Nov 21-Nov 28-Nov 05-Dec 12-Dec 19-Dec 26-Dec 02-Jan 09-Jan 16-Jan 23-Jan 30-Jan 06-Feb 13-Feb 20-Feb 27-Feb 16/9-23/9 Internal UAT for RMS and OMS 20/10-8/11 External UAT for RMS and OMS RMS go-live OMS go-live Under review Publish RMS01 and OMS01 reference materials Webinar RMS01 Webinar OMS01 Update training materials with lessons learnt from UAT Webinar OMS02 Webinar RMS02 Publish RMS02 and OMS02 reference materials Joint RMS and OMS webinar on APIs (RMS03 and OMS03) Publish videos for all modules On-boarding EU NTC Champions Publish RMS02 and OMS02 web portal user manuals Publish reference materials for APIs (RMS03 and OMS03) Attend NCA Change Liaison webinar (key agenda items include training) Identify key stakeholder groups and individuals that require training Training audiences identified Interactive delivery of nontechnical training (RMS01 and OMS01 modules) - TBC Advertise RMS01 and OMS01 webinars* Advertise RMS02 and OMS02 webinars* Advertise RMS03 and OMS03 API webinar* Provide feedback on training materials if/ when requested by SPOR Change Team 6 Key Key Programme milestones Dependency for module 2 webinars Change Liaison activities and milestones Webinars Published user manuals, videos and reference materials

8 Revision of stakeholder engagement plan Under review 7

9 Confluence one place for SPOR Change Network 8

10 Confluence one place for SPOR Change Network Create: Knowledge base articles FAQ Meeting notes Discuss: Give feedback on any page with pinned comments Possibility of using a blog Centralise: Capture information that is scattered among inboxes Organise: Communication material to share with stakeholders Share (for info) SPOR selected material presented at external conferences 9

11 Confluence one place for SPOR Change Network SPOR project and change team Collaboration /communication space for SPOR change network SPOR Change Network Stakeholders 10

12 Questions, feedback or requests for further information from wider stakeholder group EMA is receiving questions from stakeholders concerning SPOR implementation for example in specific NCA We have asked NCAs to consider setting up functional addresses that we can share We have received 11 generic addresses from Industry These contacts are published in Confluence NCA Change Liaisons have been asked to provide contact addresses that we can share 11

13 Upcoming communication activities 12

14 Upcoming communications activities Dec 2016 Update to NCA change liaisons: -Highlight published docs. -Revised timelines -SPOR on Confluence Jan 2017 Feb 2017 Mar 2017 SPOR data activities webinar, date tbc Key process changes webinar (NCAs, Industry), date tbc OMS data quality standards, doc. EMA closed SPOR reference material on EMA web: 1. Introduction to ISO IDMP 2. SPOR high level changes 3. RMS operating model 4. OMS operating model (see next slide) 13 1.SPOR data activities in 2017 (NCAs, Industry) doc. 2.Key process changes - doc. Medicines for Europe conference Revised training plan and Stakeholder engagement plan RMS & OMS operating models webinar (date tbc)

15 Recently published - SPOR reference material Introduction to ISO IDMP, SPOR programme - an introduction to standards, how they will be used to advance regulatory activities and the high-level benefits SPOR high level changes - key changes that will be brought about through the implementation of SPOR RMS operating model - summarises the operating model and its key features and includes an overview of the RMS user process and the expansion of the Referentials Lists OMS operating model - summarises the operating model and its key features and includes information on the expansion of the OMS dictionary SPOR Change Liaisons can share these directly with stakeholders and use sections of these to craft their own communication materials 14

16 Other activities Opportunity to translate SPOR related content into the EU official languages EMA to facilitate translating (change liaisons to be consulted whether this may be required / the content) Meeting with EMA stakeholders to plan the approach for the go-live communication (update to change liaisons in January) SPOR team to liaise with Committees and Working Parties Secretariats to explore possibility to present SPOR at the meetings to raise awareness Opportunity to organise DIA information day on SPOR (spring, autumn at EMA) 15

17 Thank you 16